Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain

...INDIANAPOLIS Nov. 28 /- Eli Lilly and Company... The decision does not affect duloxetine's FDA-approved indications... Lilly submitted the chronic pain application in the second quarter... This was a difficult decision but we believe the updated data pa...

INDIANAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from
the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl)
for the management of chronic pain. Lilly plans to resubmit the application in
the first half of 2009, adding data from a recently completed positive study
in chronic osteoarthritis pain of the knee.

The decision does not affect duloxetine's FDA-approved indications for
major depressive disorder, generalized anxiety disorder, management of
diabetic peripheral neuropathic pain and management of fibromyalgia.

Lilly submitted the chronic pain application in the second quarter of 2008
based primarily on outcomes of three clinical trials: one positive study in
chronic osteoarthritis pain of the knee(i) and two studies(ii,iii), -- one
positive and one that is supportive but didn't meet its primary endpoint -- in
chronic low back pain. In discussions between Lilly and the FDA, agency
reviewers raised questions about efficacy and dosing that revolved primarily
around statistical methodology and study design.

"This was a difficult decision, but we believe the updated data package
will give the FDA a broader basis for reviewing our application," said John
Hayes, M.D., a Lilly Research Laboratories vice president at Lilly.

Chronic pain affects more than 50 million Americans(iv) and pain is a
major cause of work absenteeism, underemployment and
unemployment.(v,vi,vii,viii)

About Duloxetine

Serotonin and norepinephrine in the brain and spinal cord are believed to
both mediate core mood symptoms and help regulate the perception of pain.
Based on preclinical studies, Duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine that is believed to potentiate the
activity of these chemicals in the central nervous system (brain and spinal
cord). While the exact mechanism of action of Duloxetine is unknown,
scientists believe its effects on depression and anxiety symptoms, as well as
its effect on pain perception, may be due to increasing the activity of
serotonin and norepinephrine in the central nervous system.

Duloxetine is approved in the United States for the acute and maintenance
treatment of major depressive disorder, the acute treatment of generalized
anxiety disorder, and the management of diabetic peripheral neuropathic pain
and fibromyalgia in adults age 18 years and older. Duloxetine is not approved
for use in pediatric patients.

Important Safety Information

Duloxetine is approved to treat major depressive disorder and generalized
anxiety disorder, and to manage diabetic peripheral neuropathic pain and
fibromyalgia. Antidepressants can increase suicidal thoughts and behaviors in
children, adolescents, and young adults. Patients should call their doctor
right away if they experience new or worsening depression symptoms, unusual
changes in behavior, or thoughts of suicide. Be especially observant within
the first few months of treatment or after a change in dose. Duloxetine is
approved only for adults 18 and over.

Duloxetine is not for everyone. Patients should not take Duloxetine if
they have recently taken a type of antidepressant called a monoamine oxidase
inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or have uncontrolled
glaucoma. Patients should speak with their doctor about any medical conditions
they may have including kidney problems, glaucoma, or diabetes. Patients
should talk to their doctor if they have itching, right upper belly pain, dark
urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be
signs of liver problems. Severe liver problems, sometimes fatal, have been
reported. They should also talk to their doctor about alcohol consumption.
Patients should tell their doctor about all their medicines, including those
for migraine, to avoid a potentially life-threatening condition. Taking
Duloxetine with NSAID pain relievers, aspirin, or blood thinners may increase
bleeding risk. Patients should consult with their doctor before stopping
Duloxetine or changing the dose and if they are pregnant or nursing.

Patients taking Duloxetine may experience dizziness or fainting upon
standing. The most common side effects of Duloxetine include nausea, dry
mouth, sleepiness, and constipation. This is not a complete list of side
effects.

For full Prescribing Information, including Boxed Warning and medication
guide, visit www.Cymbalta.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at www.lilly.com.

P-LLY

This press release contains forward-looking statements about the potential
of Duloxetine for the management of chronic pain, and reflects Lilly's current
beliefs. However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of development and commercialization.
There is no guarantee that the resubmission will occur as currently planned,
that the product will receive regulatory approval for chronic pain, or that it
will continue to be commercially successful. For further discussion of these
and other risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to update
forward-looking statements.

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